©2022 Stanford Medicine
Vinblastine/Prednisone Versus Single Therapy With Cytarabine for Langerhans Cell Histiocytosis (LCH)
Recruiting
I'm InterestedTrial ID: NCT02670707
Purpose
Langerhans Cell Histiocytosis (LCH) is a type of cancer that can damage tissue or cause
lesions to form in one or more places in the body. Langerhans cell histiocytosis (LCH) is a
cancer that begins in LCH cells (a type of dendritic cell which fights infection). Sometimes
there are mutations (changes) in LCH cells as they form. These include mutations of the BRAF
gene. These changes may make the LCH cells grow and multiply quickly. This causes LCH cells
to build up in certain parts of the body, where they can damage tissue or form lesions.
For most patients with LCH, standard-of-care vinblastine/prednisone are used as front-line
therapy while cytarabine therapy has been used as therapy for patients who develop
recurrence. No alternate treatment strategy has been developed for frontline therapy in LCH.
The purpose of this research study is to compare previously used vinblastine/prednisone to
single therapy with cytarabine for LCH. We will evaluate the utility of an imaging study
called a positron emission tomography (PET) scan to more accurately assess areas of LCH
involvement not otherwise seen in other imaging studies as well as response to therapy. We
also want to identify if genetic and other biomarkers (special proteins in patient's blood
and in patient's cancer) relate to the response of patients LCH to study treatment.
Official Title
Randomization of Cytarabine Monotherapy Versus Standard-of-Care Vinblastine/Prednisone for Frontline Treatment of Langerhans Cell Histiocytosis (TXCH LCH0115)
Stanford Investigator(s)
Eligibility
Inclusion Criteria:
1. Patient must have biopsy-confirmed diagnosis of Langerhans cell histiocytosis.
2. Patient must be between 0-21 years of age.
3. Patient must have a Karnofsky performance score ≥ 50% or Lansky performance score ≥
50%.
Exclusion Criteria:
1. Patient may not have received any prior systemic cytotoxic or other chemotherapies for
LCH or any other malignant disorder prior to the initiation of protocol therapy on
TXCH LCH0115 with the exception of:
Steroid pretreatment: Systemic glucocorticosteroids (prednisone, methylprednisone,
dexamethasone, etc.) for less than or equal to 120 hours (5 days) in the 7 days prior
to initiating protocol therapy or for less than or equal to 336 hours (14 days) in the
28 days before the initiation of protocol therapy does not affect eligibility. The
dose of steroid previously given does not affect eligibility. Patients who have only
received surgical or radiation therapy, intralesional injection of steroids,
inhalational steroids, systemic mineralocorticoids (hydrocortisone), or topical
steroids may also be enrolled.
2. Patient may not have disease limited to a single skin or bone site, with the following
exceptions:
- Central Nervous System (CNS) risk lesions/special site disease: patients with
single bone sites that are CNS-risk (sphenoid, mastoid, orbital, zygomatic,
ethmoid, maxillary, or temporal bones, the cranial fossa, pituitary gland or
neurodegenerative disease) or are "special sites" (odontoid peg, vertebral lesion
with intraspinal soft tissue extension) require systemic therapy as standard of
care and thus are eligible for the study.
- Functionally critical lesions: A single lesion not described above which may
cause "functionally critical anatomic abnormality" wherein attempts at local
therapy (such as surgical curettage or radiation) would cause unacceptable
morbidity. These patients may be enrolled with written approval of the
Coordinating Center PI or Vice-Chair and documentation of the rationale
justifying systemic therapy.
- Asynchronous multisite LCH presentation: A patient may also have any single site
of disease involvement at the time of enrollment if they previously had at least
one other site of LCH disease in the past (which may have been treated with local
therapy/surgery as described), as long as no systemic therapy was previously
given per protocol guidelines.
3. Patient may not have severe renal disease (creatinine greater than 3 times normal for
age OR creatinine clearance < 50 ml/m2/1.73m^2).
4. Patient may not have severe hepatic disease (direct bilirubin greater than 3 mg/dl OR
aspartate aminotransferase (AST) greater than 500 IU/L), unless hepatic injury is due
to LCH.
5. Female patients may not be pregnant or breastfeeding.
6. Patients of reproductive potential not willing to use an adequate method of birth
control for the duration of the study.
7. Patients who are HIV positive may not be enrolled.
NOTE: Patients excluded for laboratory abnormalities or performance score only may be
enrolled on the study with written approval from the Coordinating Center PI or Vice-Chair.
Intervention(s):
drug: Cytarabine
drug: Vinblastine/prednisone
Recruiting
I'm InterestedContact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Erin Rosales
650-736-3518.